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Singapore HSA registration DE0508858

Schiller AG FRED easyport plus Automated External Defibrillator

Singapore flagSingapore·CLASS C·Schiller AG·Registered January 17, 2024
Device classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0508858
Registration Date
January 17, 2024
Change Notification Approval Date
November 22, 2024
Retention Due Date
January 16, 2026
Product description
The FRED easyport plus is a defibrillator with the possibility to deliver a shock either in semi-automatic, fully-automatic or manual mode. FRED easyport plus® is intended to be used to terminate cardiac arrhythmia such as Ventricular Fibrillation or Ventricular Tachycardia with a defibrillation shock. The intended patient population are adults >25 kg and children weighing less than 25 kg (younger than 8 years of age). The portable device is intended to be used in following environmental: – Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft) patient’s homes or work places.
Product Owner
Name
Schiller AG
Short Name
Schiller AG
Address
Altgasse 68, CH-6341 Baar, SWITZERLAND
Registrant
Name
Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Importer
Name
Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552
Model information
Model Name(s)
Securing pads LifePoint feedback sensor Argus LifePoint feedback sensor FRED easyport plus FRED easyport plus FRED easyport plus
Model Identifier(s)
2.100519 2.10086 3.94006 3.940063 3.940066
About this record

Access comprehensive regulatory information for Schiller AG FRED easyport plus Automated External Defibrillator in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508858 and owned by Schiller AG. The device was registered on January 17, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C